510(k) · Cleared
ClearedIntelliflow Respiratory Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simtec, Inc. · BZC Calculator, Pulmonary Function Data
Cleared on Nov 26, 1997 after a 264-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 26, 1997
- Review
- 264 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZC device
- #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZC
Too few BZC 510(k)s in any year since 2007 to give a median.
Recalls per year · BZC
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZC
3in 2025
MAUDE reports naming product code BZC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO_ analysis. The Intelliflow unit was tested at LDS Hospital to verify that it conforms to the 24 wave forms recommended by the American Thoracic Society Standard of Spirometry, Am. Rev. Respir. Dis. 1987;136, 1285-1298. The Intelliflow does not meet the ATS guidelines for accuracy. The following five wave forms have not been qualified for…
Read the full statement (131 words)
The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO_ analysis. The Intelliflow unit was tested at LDS Hospital to verify that it conforms to the 24 wave forms recommended by the American Thoracic Society Standard of Spirometry, Am. Rev. Respir. Dis. 1987;136, 1285-1298. The Intelliflow does not meet the ATS guidelines for accuracy. The following five wave forms have not been qualified for accuracy according to the LFS simulator: #3FVC, #15MMEF, #21FVC, #23FVC, #24FVC. A copy of the actual results is enclosed with the operator's manual. Please contact SIMTEC for an explanation of the differences in the LDS simulator results and the method used by SIMTEC to verify the accuracy of all 24 wave forms. This device is not intended for patient monitoring.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970840: Intelliflow Respiratory Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970840
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026